Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - filgrastim(genetical recombination) [filgrastim biosimilar2] - injection

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nichi-iko pharmaceutical co.,ltd - filgrastim(genetical recombination) [filgrastim biosimilar 2] - injection

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.mobilisation of peripheral blood progenitor cells (pbpc).in children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.treatment of persistent neutropenia (anc ≤ 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

European Union - English - EMA (European Medicines Agency)

ratiopharm gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.ratiograstim is indicated for the treatment of persistent neutropenia (anc ≤ 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

European Union - English - EMA (European Medicines Agency)

teva gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulants, - tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (pbpc).in patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (anc) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.tevagrastim is indicated for the treatment of persistent neutropenia (anc less than or equal to 1.0 x 109/l) in patients with advanced hiv infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.12mg - solution for injection - 120 mcg/0.2ml - active: filgrastim 0.12mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011 

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.3mg - solution for injection - 300 mcg/0.5ml - active: filgrastim 0.3mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011 

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - filgrastim 0.48mg - solution for injection - 480 mcg/0.5ml - active: filgrastim 0.48mg excipient: glacial acetic acid nitrogen polysorbate 80 sodium hydroxide sorbitol water for injection - established cytotoxic chemotherapy nivestim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. the safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. peripheral blood progenitor cell mobilisation (pbpc) nivestim is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic pbpc). severe chronic neutropenia (scn) long term administration of nivestim is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an absolute neutrophil count (anc) hiv infection nivestim is indicated for the treatment of persistent neutropenia (anc latest regulatory activityapplication dateapplication typechange(s)statuspayment datepriority6/12/2023changed medicine notificationcontraindications, warnings and precautions - g2; administrative fee (cmn)granted 9/1/202420/12/2023 13/4/2011new higher-risk medicine applicationabridged new higher-risk medicine not containing a new active substancegranted 24/5/201218/4/2011 

United States - English - NLM (National Library of Medicine)

mylan institutional llc - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . although available data with fulphila or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. preterm deliveries have been reported in some patients. pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fulphila and any potential adverse effects on the breastfed child from fulphila or from the underlying maternal condition. the safety and effectiveness of pegfilgrastim have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. no overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

United States - English - NLM (National Library of Medicine)

biocon biologics inc. - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . although available data with fulphila or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. preterm deliveries have been reported in some patients. pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fulphila and any potential adverse effects on the breastfed child from fulphila or from the underlying maternal condition. the safety and effectiveness of pegfilgrastim have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. no overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.